Mednax to Present at Morgan Stanley 19th Annual Global Healthcare Conference

Mednax to Present at Morgan Stanley 19th Annual Global Healthcare Conference

FORT LAUDERDALE, Fla.–(BUSINESS WIRE)–
Mednax, Inc. (NYSE: MD) today announced that it will present on Wednesday, September 15, 2021 at 12:30 p.m. ET to investors attending Morgan Stanley’s 19th Annual Global Healthcare Conference, taking place virtually. The presentation will be broadcast through live audio webcasts.

ABOUT MEDNAX

Mednax, Inc. is a national medical group comprised of the nation’s leading providers of physician services. Physicians and advanced practitioners practicing as part of Mednax are reshaping the delivery of care within their specialties and subspecialties, using evidence-based tools, continuous quality initiatives, clinical research and telehealth programs to enhance patient outcomes and provide high-quality, cost-effective care. The Company was founded in 1979, and today, through its affiliated professional entities, Mednax provides services through a network of more than 2,300 physicians in 39 states and Puerto Rico. Additional information is available at www.mednax.com.

Certain statements and information in this press release may be deemed to contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may include, but are not limited to, statements relating to the Company’s objectives, plans and strategies, and all statements, other than statements of historical facts, that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future. These statements are often characterized by terminology such as “believe,” “hope,” “may,” “anticipate,” “should,” “intend,” “plan,” “will,” “expect,” “estimate,” “project,” “positioned,” “strategy” and similar expressions, and are based on assumptions and assessments made by the Company’s management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. Any forward-looking statements in this press release are made as of the date hereof, and the Company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the Company’s most recent Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, including the sections entitled “Risk Factors”, as well the Company’s current reports on Form 8-K, filed with the Securities and Exchange Commission, and include the impact of the COVID-19 pandemic on the Company and its financial condition and results of operations; the effects of economic conditions on the Company’s business; the effects of the Affordable Care Act and potential changes thereto or a repeal thereof; the Company’s relationships with government-sponsored or funded healthcare programs, including Medicare and Medicaid, and with managed care organizations and commercial health insurance payors; the Company’s ability to comply with the terms of its debt financing arrangements; the Company’s transition to a third-party revenue cycle management provider; the impact of the divestiture of the Company’s anesthesiology and radiology medical groups; the impact of management transitions; the timing and contribution of future acquisitions; the effects of share repurchases; and the effects of the Company’s transformation initiatives, including its reorientation on, and growth strategy for, its pediatrics and obstetrics business.

Charles Lynch

Senior Vice President, Finance and Strategy

954-384-0175 ext. 5692

[email protected]

KEYWORDS: United States North America Florida

INDUSTRY KEYWORDS: Managed Care Hospitals Health Nursing

MEDIA:

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Infosys and The Economist Group Announce Ambitious New Strategic Partnership Around Sustainability

PR Newswire

– As Digital Innovation Partner, Infosys will power The Economist Group’s latest global initiative to advance the discourse on sustainability amongst world leaders and businesses

LONDON, Sept. 8, 2021 /PRNewswire/ — Infosys (NSE: INFY) (BSE: INFY) (NYSE: INFY), a global leader in next-generation digital services and consulting, and The Economist Group, a leading global media company, today announced a new strategic partnership designed to enable and accelerate sustainability solutions and drive world-changing impact through a new business-to-business model.

With less than ten years to deliver on the 2030 Agenda for Sustainable Development, businesses and institutions must take the lead in balancing our human aspirations with the planet’s ability to sustain them. This aspiration has driven Infosys and The Economist Group to join forces to create the necessary climate for change. This initiative is designed to unlock the long-term thinking of businesses and other institutions, combining insights, innovation and influence, to address the most challenging sustainability issues facing our planet today.

The first phase of the strategic, multi-year partnership will be announced and launched in October 2021. It will combine Infosys’ groundbreaking digital services and capabilities with the strength and depth of The Economist Group’s global policy research, insights and events expertise.

By leveraging their collective strengths as two organisations with a shared commitment to sustainable business practices, the partnership will see The Economist Group and Infosys advance sustainability dialogue and inspire action towards creating a better, more sustainable world.


Lara Boro, CEO, The Economist Group,
 said: “A sustainable future will depend on creative collaboration. This exciting partnership with Infosys shows how pooling strengths can accelerate innovation and amplify impact in the pursuit of progress.”


Salil Parekh, CEO, Infosys,
emphasized: “At Infosys, our focus is to serve the preservation of our planet by shaping sustainability solutions which are driven by insights that inform, experiences that immerse, and platforms that drive action. We take great pride in leveraging the power of digital technologies to drive global business transformation. As a digital innovation partner, we are delighted to catalyze progress by supporting The Economist Group to enable global sustainability stakeholders and accelerate the agenda for global businesses towards a better, greener future.”

About The Economist Group

The Economist Group is built on high-quality, in depth global analysis which runs through all of its businesses. With 25 offices in 14 countries and serving a global readership and client base, the Group produces digital and print products, convenes global events, and offers a range of subscription and other services for clients and consumers. Its flagship businesses include The Economist, and research and analysis division, The Economist Intelligence Unit.

About Infosys Ltd.

Infosys is a global leader in next-generation digital services and consulting. We enable clients in more than 50 countries to navigate their digital transformation. With over four decades of experience in managing the systems and workings of global enterprises, we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills, expertise, and ideas from our innovation ecosystem.

Visit www.infosys.com to see how Infosys (NSE: INFY) (BSE: INFY) (NYSE: INFY), can help your enterprise navigate your next. 

Safe Harbor

Certain statements in this release concerning our future growth prospects, financial expectations and plans for navigating the COVID-19 impact on our employees, clients and stakeholders are forward-looking statements intended to qualify for the ‘safe harbor’ under the Private Securities Litigation Reform Act of 1995, which involve a number of risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. The risks and uncertainties relating to these statements include, but are not limited to, risks and uncertainties regarding COVID-19 and the effects of government and other measures seeking to contain its spread, risks related to an economic downturn or recession in India, the United States and other countries around the world, changes in political, business, and economic conditions, fluctuations in earnings, fluctuations in foreign exchange rates, our ability to manage growth, intense competition in IT services including those factors which may affect our cost advantage, wage increases in India, our ability to attract and retain highly skilled professionals, time and cost overruns on fixed-price, fixed-time frame contracts, client concentration, restrictions on immigration, industry segment concentration, our ability to manage our international operations, reduced demand for technology in our key focus areas, disruptions in telecommunication networks or system failures, our ability to successfully complete and integrate potential acquisitions, liability for damages on our service contracts, the success of the companies in which Infosys has made strategic investments, withdrawal or expiration of governmental fiscal incentives, political instability and regional conflicts, legal restrictions on raising capital or acquiring companies outside India, unauthorized use of our intellectual property and general economic conditions affecting our industry and the outcome of pending litigation and government investigation. Additional risks that could affect our future operating results are more fully described in our United States Securities and Exchange Commission filings including our Annual Report on Form 20-F for the fiscal year ended March 31, 2021. These filings are available at www.sec.gov. Infosys may, from time to time, make additional written and oral forward-looking statements, including statements contained in the Company’s filings with the Securities and Exchange Commission and our reports to shareholders. The Company does not undertake to update any forward-looking statements that may be made from time to time by or on behalf of the Company unless it is required by law.

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SOURCE Infosys

Perrigo to Acquire Leading Consumer Self-Care Company, HRA Pharma

– Transaction would complete Perrigo’s three-year transformation plan to become a global leader in consumer self-care; positions Perrigo to deliver top-tier net sales growth and double-digit EPS growth, with significant margin expansion.

– Would add HRA’s focused portfolio of market leading, high growth OTC self-care brands in blister care, women’s health and scar care to Perrigo’s expert direct go-to-market platform.

– Acquisition of HRA for €1.8 billion, or approximately $2.1 billion(1), in cash would represent an enterprise value to expected 2022 adjusted EBITDA multiple of 18x. Adding anticipated synergies expected by 2023 on a pro forma basis, purchase price would represent an adjusted EBITDA multiple of less than 14x.

– Would significantly strengthen Perrigo’s global footprint by adding scale in key European markets.

– Overlap with existing geographies expected to provide significant and actionable operational synergies.

– Transaction is anticipated to accelerate results for both Consumer Self-Care segments and be immediately accretive to Perrigo, adding approximately €400 million in net sales and approximately $1.00 in adjusted EPS in FY 2023.

– HRA’s seasoned leadership team will remain in place to minimize any business disruption from integration.

– Conference call and webcast scheduled for today, September 8, 2021, at 8:30 A.M. EDT to discuss transaction.

(1) Assumes euro/dollar exchange rate of €1.00/$1.19 as of September 7, 2021.

PR Newswire

DUBLIN, Sept. 8, 2021 /PRNewswire/ — Perrigo Company plc (NYSE, TASE: PRGO) (“Perrigo” or the “Company”) today announced that it has signed a binding offer to acquire Héra SAS (“HRA” or “HRA Pharma”), a leading global consumer self-care company, from funds affiliated with private equity firm Astorg and Goldman Sachs Asset Management. The transaction is valued at €1.8 billion, or approximately $2.1 billion in cash. HRA is one of the fastest growing over-the-counter (“OTC”) companies globally, with three category-leading self-care brands in blister care (Compeed®), women’s health (ellaOne®) and scar care (Mederma®). This scale acquisition would complete Perrigo’s transformation to a global leader in consumer self-care, bolster its presence in high-potential European markets and meaningfully improve its already strong operational and financial profile.

“Over the last two and one-half years, we have been on a journey to transform Perrigo into a focused and high-performing consumer self-care company, all while delivering a successful track record of well executed acquisitions and divestitures. The acquisition of HRA would be the crowning achievement in that transformation. With the addition of HRA and its talented leadership team, Perrigo would be a consumer self-care global leader that is poised to deliver top tier net sales growth and double-digit EPS growth in the near-term while concurrently expanding margins,” said Murray S. Kessler, CEO and President, Perrigo. “Importantly, HRA’s focused portfolio of fast-growing self-care brands, which are market share leaders in growing categories, would be accretive to Perrigo’s 3% revenue growth goal. And, HRA’s expertise in migrating products from prescription to OTC would represent even further upside. The complementary geographic footprint of HRA to that of Perrigo would allow for significant and actionable synergies. And it is the totality of these factors that makes the combination of Perrigo and HRA strategically and financially compelling. It’s literally a one-of-a-kind opportunity to simultaneously enhance our financial profile, while driving even greater value for consumers, shareholders and the communities in which we work and live.”

“I’m incredibly proud of the hard work of the HRA team, who have helped establish the company as a world-class organization – one positioned to embark on the next chapter of its journey as part of the Perrigo family,” said David Wright, CEO, HRA. “Perrigo is the ideal partner to continue growing these brands across the globe and into attractive adjacent categories, as we build on Perrigo’s platform and sizable product portfolio. We are excited about the opportunity to join the Perrigo team and with a shared vision and principles, deliver on the tremendous value opportunity of the combined business. As one of the world’s leading self-care companies, Perrigo is uniquely positioned to advance these brands for years to come.” 


Strategic Highlights

The addition of HRA would strengthen Perrigo’s OTC self-care offerings and expand its portfolio with highly recognizable consumer brands in their respective categories, including:

  • Compeed® – a well-known and trusted global OTC brand with leading market share that offers a wide variety of high-quality innovative solutions for preventing and treating blisters, bunions, calluses, corns and cracked heels, as well as its recent successful entry into cold sores as part of its strategy to expand into adjacencies including wound care;
  • ellaOne® – a women’s health OTC emergency contraception brand with leading market share, that is available without a prescription in 59 countries;
  • Mederma® – the leading U.S. OTC scar care brand with high-quality solutions for reducing the appearance of scars, stretch marks and cold sores.

Separately, approximately 15% of HRA’s net sales are derived from a rare disease portfolio of three leading prescription products.

HRA would also bring expertise and a successful track record in leading the switch of prescription-to-OTC women’s health products, evidenced by ellaOne® emergency contraception achieving OTC status in 59 countries. Of note, the HRA team recently received approval and launched Hana®, a once-daily OTC oral contraceptive in the U.K. This represents the first OTC approval of a daily oral contraceptive in the U.K. 

This transaction would bolster Perrigo’s footprint in its European markets while adding scale to its operations in key underpenetrated European markets, providing significant opportunities for additional growth.


Financial Highlights

The transaction would enable Perrigo to deliver substantial value by improving its financial profile, including growth, margins, earnings and cash flow. It would also advance Perrigo’s long-term goal to align its growth profile at the high-end of the world’s top-tier consumer packaged goods companies.

HRA’s net sales growth is expected to be in the mid-teen percentage range, with an adjusted operating margin near 30%range.

Perrigo would plan to save more than €30 million annually by 2023 from unlocking meaningful operational synergies from this transaction. Perrigo would use its existing global infrastructure to achieve selling efficiencies, streamline logistical efforts and reduce overlapping fixed costs. These synergies, along with HRA’s strong market position and attractive financial profile, are anticipated to add approximately €400 million in net sales and $1.00 in adjusted EPS in FY 2023.

After thorough consideration of capital allocation alternatives, Perrigo believes this acquisition to be the most compelling use of its capital based on the return on investment, internal rate of return and net sales growth, margin and earnings accretion compared to other alternatives. 


Transaction Terms

Perrigo has signed a binding offer to acquire HRA in a cash transaction valued at €1.8 billion, or approximately $2.1 billion, on a cash-free, debt-free basis. The agreement between Perrigo and the selling shareholders would be finalized following the information and consultation process with HRA’s Works Council in France then enabling the applicable selling shareholders to execute a put option granted by Perrigo. The proposed final transaction would close by the end of the first half of 2022, subject to the satisfaction of customary closing conditions, including regulatory approvals.

Perrigo would pay the purchase price using cash on hand at closing. In addition, Perrigo has full capacity available under its current credit facility and depending on market conditions, may also consider new debt financing. The closing of the acquisition would not be subject to a financing condition.


Perrigo Conference Call and Webcast

Perrigo will host a conference call and webcast today, September 8, 2021, at 8:30 A.M. EDT to discuss this transaction. The live conference call can be accessed via webcast to interested parties in the investor relations section of the Perrigo website at http://perrigo.investorroom.com/events-webcasts or by phone at 888-317-6003, International 412-317-6061, and reference ID # 4920640. A taped replay of the call will be available beginning at approximately 12:00 P.M. (EDT)September 8, 2021, until midnight September 15, 2021. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code10160053.


Advisors

Centerview Partners is serving as financial advisor to Perrigo. Wachtell, Lipton, Rosen & Katz and Darrois Villey Maillot Brochier are serving as its legal counsel.

Sawaya Partners, Goldman Sachs Investment Banking Division and Rothschild & Co. are serving as financial advisors to the selling shareholders. Latham & Watkins, LLP is serving as the selling shareholders’ legal counsel and Dechert LLP is serving as counsel to HRA management.


About Perrigo

Perrigo Company plc (NYSE; TASE: PRGO) is a leading provider of Quality, Affordable Self-Care Products and over-the-counter (OTC) health and wellness solutions that enhance individual well-being by empowering consumers to proactively prevent or treat conditions that can be self-managed. Led by its consumer self-care strategy, Perrigo is the largest store brand OTC player in the U.S. in the categories in which it competes through more than 9,000 SKUs under customer ‘own brand’ labels. Additionally, Perrigo is a Top 10 OTC company by revenue in Europe, where it markets more than 200 branded OTC products throughout 28 countries. Visit Perrigo online at www.perrigo.com


About HRA Pharma

HRA is a fast growing, innovative consumer healthcare company, empowering people throughout the world to improve their lives by developing accessible, value added, self-care solutions. The brand portfolio has continued to grow with a range of high-quality products in the area of consumer healthcare with a short and impressive timeframe.

Historically centered on women’s health, the company has continued to grow and has now become the European leader in emergency contraception. Its focus on Rx-to-OTC switches has seen the company grow in both strength and brand by being agile and innovative in its approach. HRA is committed to bringing a range of innovative products and services to market, particularly in areas of unmet customer needs. Headquartered in Paris, France with subsidiaries across Western Europe and a global network of local partners covering over 90 countries, the company has a proven structure, the skills and experience to capture new consumer healthcare businesses and deliver high quality brands on a global scale. Visit: www.hra-pharma.com for more information.


About Astorg

Astorg is a global private equity firm with over €13 billion of assets under management. We work with entrepreneurs and management teams to acquire market leading global companies headquartered in Europe or the US, providing them with the strategic guidance, governance and capital they need to achieve their growth goals. Astorg enjoys a distinct entrepreneurial culture, a long-term shareholder perspective and a lean decision-making body. Astorg has valuable industry expertise in healthcare, software, technology, business services and technology-based industrial companies. Astorg has offices in London, Paris, New York, Frankfurt, Milan and Luxembourg.
For more information about Astorg: www.astorg.com. Follow Astorg on LinkedIn.



About Goldman Sachs Asset Management Private Equity

Bringing together traditional and alternative investments, Goldman Sachs Asset Management provides clients around the world with a dedicated partnership and focus on long-term performance. As the primary investing area within Goldman Sachs (NYSE: GS), we deliver investment and advisory services for the world’s leading institutions, financial advisors and individuals, drawing from our deeply connected global network and tailored expert insights, across every region and market—overseeing more than $2 trillion in assets under supervision worldwide as of June 30, 2021. Driven by a passion for our clients’ performance, we seek to build long-term relationships based on conviction, sustainable outcomes, and shared success over time.  Goldman Sachs Asset Management invests in the full spectrum of alternatives, including private equity, growth equity, private credit, real estate and infrastructure. Established in 1986, the Private Equity business within Goldman Sachs Asset Management has invested over $75 billion since inception. We combine our global network of relationships, our unique insight across markets, industries and regions, and the worldwide resources of Goldman Sachs to build businesses and accelerate value creation across our portfolios. 
For more information about Goldman Sachs, please visit:


www.goldmansachs.com.
Follow Goldman Sachs Asset Management on LinkedIn.


Perrigo Forward-Looking Statements

Certain statements in this press release are “forward-looking statements.” These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “will,” “could,” “would,” “should,” “expect,” “forecast,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “poised,” “predict,” “potential” or the negative of those terms or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company’s control, including: the effect of the novel coronavirus (COVID-19) pandemic and the associated supply chain impacts on the Company’s business; general economic, credit, and market conditions; future impairment charges; customer acceptance of new products; competition from other industry participants, some of whom have greater marketing resources or larger market shares in certain product categories than the Company does; pricing pressures from customers and consumers; resolution of uncertain tax positions, including the Company’s appeal of the Notice of Assessment (the “NoA”) issued by the Irish tax authority and the draft and final Notices of Proposed Assessment (“NOPAs”) issued by the U.S. Internal Revenue Service and the impact that an adverse result in any such proceedings would have on operating results, cash flows, and liquidity; pending and potential third-party claims and litigation, including litigation relating to the Company’s restatement of previously-filed financial information and litigation relating to uncertain tax positions, including the NoA and the NOPAs; potential impacts of ongoing or future government investigations and regulatory initiatives; potential costs and reputational impact of product recalls or sales halts; the impact of tax reform legislation and healthcare policy; the timing, amount and cost of any share repurchases; fluctuations in currency exchange rates and interest rates; the success of the sale of the Rx business, including the ability to achieve the expected benefits thereof and the risk that potential costs or liabilities incurred or retained in connection with the transaction may exceed the Company’s estimates or adversely affect the Company’s business or operations; the consummation and success of the proposed acquisition of HRA and the ability to achieve the expected benefits thereof, including the risk that the works council consultation process is lengthier than anticipated, the risk that the parties fail to obtain the required regulatory approvals or to fulfill the other conditions to closing on the expected timeframe or at all, the occurrence of any other event, change or circumstance that could delay the transaction or result in the termination of the put option agreement or securities sale agreement or the risks that Company’s synergy estimates are inaccurate or that the Company faces higher than anticipated integration or other costs in connection with the proposed acquisition; the consummation and success of other announced acquisitions or dispositions, and the Company’s ability to realize the desired benefits thereof; and the Company’s ability to execute and achieve the desired benefits of announced cost-reduction efforts and strategic and other initiatives. An adverse result with respect to the Company’s appeal of any material outstanding tax assessments or pending litigation, including securities or drug pricing matters, could ultimately require the use of corporate assets to pay such assessments, damages from third-party claims, and related interest and/or penalties, and any such use of corporate assets would limit the assets available for other corporate purposes. These and other important factors, including those discussed under “Risk Factors” in the Company’s Form 10-K for the year ended December 31, 2020, as well as the Company’s subsequent filings with the United States Securities and Exchange Commission (“SEC”), may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


Non-GAAP Measures

This press release contains certain non-GAAP measures. A “non-GAAP financial measure” is defined as a numerical measure of a company’s financial performance that excludes or includes amounts different from the most directly comparable measure calculated and presented in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”) in the statements of operations, balance sheets or statements of cash flows of the Company. Pursuant to the requirements of the SEC, the Company has provided reconciliations to the most directly comparable U.S. GAAP measures for the following non-GAAP financial measures referred to in this press release:

  • adjusted EPS.

These non-GAAP financial measures should be considered as supplements to the GAAP reported measures, should not be considered replacements for, or superior to the GAAP measures and may not be comparable to similarly named measures used by other companies.

The Company provides non-GAAP financial measures as additional information that it believes is useful to investors and analysts in evaluating the performance of the Company’s ongoing operating trends, facilitating comparability between periods and, where applicable, with companies in similar industries and assessing the Company’s prospects for future performance. These non-GAAP financial measures exclude items, such as impairment charges, restructuring charges, and acquisition and integration-related charges, that by their nature affect comparability of operational performance or that we believe obscure underlying business operational trends. The intangible asset amortization excluded from these non-GAAP financial measure represents the entire amount recorded within the Company’s GAAP financial statements and is excluded because the amortization, unlike the related revenue, is not affected by operations of any particular period unless an intangible asset becomes impaired or the estimated useful life of an intangible asset is revised. The revenue generated by the associated intangible assets has not been excluded from the related non-GAAP financial measure. The non-GAAP measures the Company provides are consistent with how management analyzes and assesses the operating performance of the Company, and disclosing them provides investor insight into management’s view of the business. Management uses these adjusted financial measures for planning and forecasting in future periods, and evaluating segment and overall operating performance. In addition, management uses certain of the profit measures as factors in determining compensation.

Non-GAAP measures related to profit measurements, which include adjusted EPS, are useful to investors as they provide them with supplemental information to enhance their understanding of the Company’s underlying business performance and trends, and enhance the ability of investors and analysts to compare the Company’s period-to-period financial results. The Company believes these supplemental financial measures provide investors with consistency in financial reporting, enabling meaningful comparisons of past, present and future underlying operating results, and also facilitate analysis of the Company’s operating performance and acquisition and divestiture trends.

As it relates to the projected impact of the acquisition on adjusted earnings per share in FY 2023, the Company has not provided a reconciliation to diluted earnings per share as presented herein because it is unable to determine the ultimate outcome of certain significant items necessary to calculate such measures without unreasonable effort. These items include, but are not limited to, certain non-recurring items that are uncertain, depend on various factors, and could have a material impact on the U.S. GAAP reported results for the guidance period.

 

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SOURCE Perrigo Company plc

Nuvalent Announces Business and Program Highlights and Reports Second Quarter 2021 Financial Results

IND Application for NVL-520 Cleared by US FDA; Company Expects to Initiate Phase 1/2 Clinical Trial in Second Half of 2021

$190.6 Million Upsized IPO Completed to Fund Continued Advancement of Novel Portfolio of Precisely Targeted Kinase Inhibitors

Leadership Team Further Strengthened with Appointments of Deborah Miller, Ph.D., J.D., as Chief Legal Officer and Sapna Srivastava, Ph.D., to the Board of Directors

PR Newswire

CAMBRIDGE, Mass., Sept. 8, 2021 /PRNewswire/ — Nuvalent, Inc., (Nasdaq: NUVL), a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today reported recent pipeline and business highlights and second quarter 2021 financial results.

“At Nuvalent, we are leveraging our team’s deep expertise in chemistry and structure-based drug design to advance a novel pipeline of product candidates for patients with cancer. Our therapies are specifically designed to solve for challenges limiting the activity and durability of currently available therapies, such as kinase resistance, adverse events due to off-target activity, and metastases to the brain,” said James Porter, Ph.D., Chief Executive Officer at Nuvalent. “In the first half of 2021, our team has made meaningful progress to deliver on our clear vision for advancing the field of precision oncology. We have received clearance from the FDA to proceed with the Phase 1/2 study for our ROS1-selective inhibitor NVL-520, advanced our parallel lead product candidate, the ALK-selective inhibitor NVL-655, into IND-enabling studies, and progressed multiple additional discovery-stage research programs. With the recent talented additions to our team and capital raised in our upsized IPO, we stand well positioned to fuel our upcoming transition to a clinical organization and efforts to renew hope for patients in need.”

Second Quarter Highlights

  • IND Application for NVL-520 Cleared by FDA, Enabling Clinical Trial Initiation: The U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for NVL-520, its brain-penetrant ROS1-selective inhibitor. The company is preparing to initiate the Phase 1 portion of a global, Phase 1/2 clinical trial for NVL-520 in patients with ROS1-positive NSCLC and other advanced solid tumors in the second half of 2021.


  • $190.6 Million Upsized Initial Public Offering (IPO) Successfully Completed
    : In July 2021, Nuvalent sold 11,212,500 shares of common stock at a price to the public of $17.00 per share. The gross proceeds from the offering were approximately $190.6 million, before deducting underwriting discounts and commissions and other offering expenses.

  • Company Leadership Strengthened through Appointments to Management and Board: Nuvalent recently appointed Deborah Miller, Ph.D., J.D., as Chief Legal Officer, and Sapna Srivastava, Ph.D., Chief Financial Officer of eGenesis, to its Board of Directors.

Dr. Miller most recently served as Senior Vice President, Deputy General Counsel and Chief IP Counsel for Sumitomo Dainippon Pharma America (SDPA). Prior to that, Dr. Miller served as Deputy General Counsel and Chief IP Counsel at Sunovion Pharmaceuticals Inc., a subsidiary of SDPA. She previously held various roles at Infinity Pharmaceuticals, Inc. including Vice President, Deputy General Counsel and Chief Patent Counsel, where she built and managed the intellectual property group and supported various in-licensing, out-licensing and financing ventures. Earlier in her career, Dr. Miller was IP corporate counsel at Sepracor Inc. (currently, Sunovion Pharmaceuticals Inc.), and an associate at the law firm Nutter McClennen & Fish LLP. Dr. Miller earned her J.D. from Suffolk University Law School, Ph.D. in biological chemistry and molecular pharmacology from Harvard University, M.S. in medical sciences from Harvard Medical School and B.S. in chemistry from Swarthmore College.

Dr. Srivastava brings over 20 years of experience as a senior executive in the biopharmaceutical industry. She has served as the Chief Financial Officer at eGenesis Bio since April 2021. Prior to eGenesis, she held similar roles as the Chief Financial and Strategy Officer at Abide Therapeutics (acquired by Lundbeck) and at Intellia Therapeutics. Before Intellia, Dr. Srivastava was a senior biotechnology analyst at Goldman Sachs, Morgan Stanley and ThinkEquity Partners, and began her career as a research associate at J.P. Morgan. Dr. Srivastava received her Ph.D. in neuroscience from the New York University School of Medicine and her B.S. in biology from St. Xavier’s College at the University of Bombay.

Second Quarter 2021 Financial Results

  • As of June 30, 2021, Nuvalent had cash of $138.9 million, which does not include net proceeds from its IPO, which was completed on August 2, 2021. 
  • Research & Development expenses for the second quarter of 2021 were $7.8 million.
  • General & Administrative expenses for the second quarter of 2021 were $2.0 million.
  • Net Loss for the second quarter was $9.8 million, or $3.17 per share.

About Nuvalent

Nuvalent, Inc. (Nasdaq: NUVL) is a preclinical stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with parallel lead programs in ROS1-positive and ALK-positive NSCLC, along with multiple discovery-stage research programs. To learn more, visit www.nuvalent.com and follow us on Twitter (@nuvalent) and LinkedIn.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Nuvalent, Inc.’s (“Nuvalent,” the “Company,” “we,” or “our”) strategy, business plans and focus; the progress and timing of the preclinical and clinical development of Nuvalents’ programs, including NVL-520 and NVL-655; expectations regarding the planned clinical trial initiation of NVL-520, including timing; expectations regarding Nuvalent’s use of capital, expenses and other financial results during 2021 and in the future. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” or the negative of these terms and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 on countries or regions in which the Company has operations or does business, as well as on the timing and anticipated timing and results of its clinical trials, strategy and future operations, including the planned initiation of the Phase 1 portion of a global, Phase 1/2 clinical trial for NVL-520, the timing and progress of IND-enabling studies of NVL-655 and progress from the Company’s discovery-stage programs; the Company’s expectations regarding its management and board additions; the Company’s ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of Nuvalent’s planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Nuvalent’s views only as of today and should not be relied upon as representing our views as of any subsequent date. Nuvalent explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

 


STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS


(In thousands, except share and per share data)


(Unaudited)


Three Months Ended June
 
30,


Six Months Ended June
 
30,


2021


2020


2021


2020

Operating expenses:

Research and development

$

7,826

$

3,657

$

13,310

$

6,983

General and administrative

2,024

349

2,702

668

Total operating expenses

9,850

4,006

16,012

7,651

Loss from operations

(9,850)

(4,006)

(16,012)

(7,651)

Other income (expense):

Change in fair value of preferred     

   stock tranche rights

(4,542)

(635)

4,471

Other income (expense), net

12

(9)

24

(18)

Total other income (expense), net

12

(4,551)

(611)

4,453

Net loss and comprehensive loss

$

(9,838)

$

(8,557)

$

(16,623)

$

(3,198)

Net loss per share attributable to

   common stockholders, basic and

   diluted

$

(3.17)

$

(2.82)

$

(5.37)

$

(1.20)

Weighted average shares of common

   stock outstanding, basic and diluted

3,106,152

3,037,974

3,095,639

2,675,827

 

 


SELECTED BALANCE SHEET DATA


(In thousands)


(Unaudited)


June
 
30,


December
 
31,


2021


2020

Cash

$

138,919

$

10,332

Working capital

$

133,452

$

6,266

Total assets

$

143,502

$

10,646

Total liabilities

$

5,829

$

6,615

Total stockholders’ deficit

$

(47,740)

$

(31,323)

 

 

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SOURCE Nuvalent, Inc.

Immunic, Inc. to Participate in Investor and Scientific Conferences in September

PR Newswire

NEW YORK, Sept. 8, 2021 /PRNewswire/ — Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, today announced participation in the following investor and scientific conferences in September:

  • September 13-15: H.C. Wainwright 23rd Annual Global Investment Conference. Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic, will present a company overview at the conference. The on-demand presentation will be available for viewing beginning September 13, at 7:00 am ET. An audio webcast of the presentation will be available on the “Events and Presentations” section of Immunic’s website at: ir.imux.com/events-and-presentations. An archived replay will be available on the company’s website for a period of 90 days after the conference.
     
  • September 22-25: 50th Annual European Society for Dermatological Research (ESDR) Meeting. Irina Betscheider, Ph.D., Clinical Operations Program Lead at Immunic, will present the first clinical experience with IMU-935, an orally available, selective inverse agonist of RORγt. The poster presentation will be accessible on the “Events and Presentations” section of Immunic’s website at: ir.imux.com/events-and-presentations.
    • Poster Number: ESDR057
    • Title: Safety, tolerability and pharmacokinetics of single and multiple oral doses of IMU-935 in healthy volunteers: First clinical experience with an orally available small molecule inhibitor of IL-17
       
  • September 27-30: 2021Cantor Virtual Global Healthcare Conference. Dr. Vitt will participate in a fireside chat on Tuesday, September 28, at 10:00 am ET. A live audio webcast of the presentation will be available on the “Events and Presentations” section of Immunic’s website at: ir.imux.com/events-and-presentations. An archived replay will be available on the company’s website for a period of 90 days.

About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases. The company is developing three small molecule products: its lead development program, IMU-838, a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH and exhibits a host-based antiviral effect, is currently being developed as a treatment option for multiple sclerosis, ulcerative colitis, Crohn’s disease, and primary sclerosing cholangitis. IMU-935, a selective inverse agonist of the transcription factor RORγt, is targeted for development in psoriasis, castration-resistant prostate cancer and Guillain-Barré syndrome. IMU-856, which targets the restoration of the intestinal barrier function, is targeted for development in diseases involving bowel barrier dysfunction. For further information, please visit: www.imux.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to management’s participation in investor and scientific conferences. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned “Risk Factors,” in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed with the SEC on February 26, 2021, and in the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.

Contact Information

Immunic, Inc.

Jessica Breu

Head of Investor Relations and Communications
+49 89 2080 477 09
[email protected]

US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 322 2216
[email protected]

US Media Contact
KOGS Communication
Edna Kaplan
+1 781 639 1910
[email protected]

 

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SOURCE Immunic, Inc.

Hyster-Yale Materials Handling, Inc. to Participate in Sidoti 2021 Fall Virtual Small Cap Conference

PR Newswire

CLEVELAND, Sept. 8, 2021 /PRNewswire/ — Hyster-Yale Materials Handling, Inc. (NYSE:HY) announced today that it will participate in the Sidoti 2021 Fall Virtual Small Cap Conference on Wednesday, September 22, 2021. 

The Company’s presentation is scheduled to start at 1:00 pm ET and will be webcast. To access the webcast, please visit www.hyster-yale.com at least 15 minutes prior to the event.


About Hyster-Yale Materials Handling
 
Hyster-Yale Materials Handling, Inc., headquartered in Cleveland, Ohio, offers a broad array of solutions to meet the specific materials handling needs of customers’ applications. The Company’s wholly owned operating subsidiary, Hyster-Yale Group, Inc., designs, engineers, manufactures, sells and services a comprehensive line of lift trucks and aftermarket parts marketed globally primarily under the Hyster® and Yale® brand names. Subsidiaries of Hyster-Yale include Nuvera Fuel Cells, LLC, an alternative-power technology company focused on fuel cell stacks and engines, and Bolzoni S.p.A., a leading worldwide producer of attachments, forks and lift tables marketed under the Bolzoni®, Auramo® and Meyer® brand names. Hyster-Yale also has significant joint ventures in Japan (Sumitomo NACCO) and in China (Hyster-Yale Maximal). For more information about Hyster-Yale and its subsidiaries, visit the Company’s website at www.hyster-yale.com.  

***

 

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SOURCE Hyster-Yale Materials Handling, Inc.

HUTCHMED and AstraZeneca Initiate SANOVO Phase III Trial of ORPATHYS® and TAGRISSO® Combination as a First-Line Therapy for Certain Lung Cancer Patients in China

— Follows important findings from the SAVANNAH study of this combination in lung cancer patients whose tumors harbor mutations or aberrations of EGFR and MET —

HONG KONG, SHANGHAI, China and FLORHAM PARK, N.J., Sept. 08, 2021 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) and AstraZeneca PLC (“AstraZeneca”) (LSE/STO/Nasdaq:AZN) have initiated SANOVO, a China Phase III study of ORPATHYS® (savolitinib), an oral, potent, and highly selective MET tyrosine kinase inhibitor (“TKI”), in combination with AstraZeneca’s third-generation, irreversible epidermal growth factor receptor (“EGFR”) TKI, TAGRISSO® (osimertinib) as a first-line treatment in certain non-small cell lung cancer (“NSCLC”) patients whose tumors harbor EGFR mutation and overexpress MET. The first patient was dosed on September 7, 2021.

The Phase III trial is a blinded, randomized, controlled study in previously untreated patients with locally advanced or metastatic NSCLC with activating EGFR mutations and MET overexpression. The study will evaluate the efficacy and safety of TAGRISSO® in combination with ORPATHYS® comparing to TAGRISSO® alone, a standard-of-care treatment option for these patients. The primary endpoint of the study is median progression free survival (“PFS”) as assessed by investigators. Other endpoints include median PFS assessed by an independent review committee, median overall survival (“OS”), objective response rate (“ORR”), duration of response (“DoR”), disease control rate (“DCR”), time to response (TTR), and safety. Additional details may be found at clinicaltrials.gov, using identifier NCT05009836.

About NSCLC, EGFR and MET Aberrations

Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths.1 More than a third of the world’s lung cancer patients are in China.2   Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.3 The majority of NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis.4,5 For patients with resectable tumors, the majority of patients eventually develop recurrence despite complete tumor resection and adjuvant chemotherapy.6

Approximately 10-25% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFR-mutated NSCLC.7,8,9 These patients are particularly sensitive to treatment with an EGFR TKI which blocks the cell-signaling pathways that drive the growth of tumor cells.10

MET is a tyrosine kinase receptor.11 Aberration of MET (amplification or overexpression) is present in both treatment naïve patients as well as being one of the primary mechanisms of acquired resistance to EGFR TKIs for metastatic EGFR-mutated NSCLC. 12,13

About Savolitinib (ORPATHYS

®

in China)

Savolitinib is an oral, potent, and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations) or gene amplification.

Savolitinib is marketed in China under the brand name ORPATHYS® for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, as a single treatment and in combination with other medicines.

In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize savolitinib. Joint development in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of savolitinib in China. AstraZeneca is responsible for the commercialization of savolitinib in China and worldwide. Sales of savolitinib are recognized by AstraZeneca.

Savolitinib development in NSCLC


Phase II study of savolitinib


monotherapy in MET Exon 14 skipping alteration NSCLC (


NCT02897479


)
– In June 2021, savolitinib was granted drug registration conditional approval by the National Medical Products Administration of China (NMPA) for MET Exon 14 skipping alteration NSCLC. The approval was based on the results of a Phase II study in China; results of this study were published in The Lancet Respiratory Medicine14. At a median follow up of 17.6 months, savolitinib demonstrated an ORR of 42.9% (95% confidence interval [CI] 31.1-55.3) and median PFS of 6.8 months (95% CI 4.2-9.6) in the overall trial population. DCR in the overall trial population was 82.9% (95% CI 72.0-90.8). The safety and tolerability profile of savolitinib was consistent with previous trials, and no new safety signals were identified. Continued approval is contingent upon the successful completion of a confirmatory trial in this patient population (NCT04923945).


TATTON Phase Ib/II expansion studies of savolitinib in combination with TAGRISSO



®



in patients who have progressed following EGFR TKI treatment due to MET amplification (


NCT02143466


)
– This global exploratory study in over 220 EGFR mutation positive NSCLC patients with MET amplified tumors following progression after treatment with any EGFR TKI. Results were published in Lancet Oncology15 and final analysis was presented at the World Conference on Lung Cancer16. Three cohorts with patients treated following progression on first- or second-generation EGFR TKI demonstrated an ORR of 64.7-66.7% and a median PFS of 9.0-11.1 months. The cohort of patients treated following progression on a third-generation EGFR TKI demonstrated an ORR of 33.3% (95% CI 22.4-45.7), with a median PFS of 5.5 months (95% CI 4.1-7.7). The combination demonstrated encouraging anti-tumor activity and an acceptable risk-benefit profile.


SAVANNAH Phase II study of savolitinib in combination with TAGRISSO


®


in patients who have progressed following TAGRISSO



®



due to MET amplification or overexpression (


NCT03778229


)
– This is a single-arm, open-label, global study in epidermal growth factor receptor (“EGFR”) mutation positive NSCLC patients with MET amplified/overexpressed tumors following progression after treatment with TAGRISSO®, an EGFR TKI owned by AstraZeneca.


SACHI Phase III study of savolitinib in combination with TAGRISSO



®



in patients who have progressed following EGFR TKI treatment due to MET amplification (


NCT05015608


)
– This is a randomized, open-label study in China in EGFR mutation positive NSCLC patients with MET amplified tumors following progression after treatment with any EGFR TKI.


SANOVO Phase III study of savolitinib in combination with TAGRISSO



®



in treatment-naïve patients with EGFR mutant positive NSCLC with MET overexpression (


NCT05009836


)
– This is a randomized, blinded study in China in untreated, unresectable or metastatic patients with EGFR mutation positive NSCLC with MET positive tumors.

Savolitinib development in kidney cancer


SAVOIR randomized, controlled study of ORPATHYS



®



monotherapy in MET-driven papillary renal cell carcinoma (“RCC”) (


NCT03091192


)
– In May 2020, data from 60 patients in this global study of savolitinib monotherapy compared with sunitinib monotherapy in MET-driven papillary RCC was presented at the ASCO 2020 Program and published simultaneously in JAMA Oncology17. Savolitinib demonstrated encouraging activity, including an ORR of 27% versus 7% for sunitinib, with no savolitinib responding patients experiencing disease progression at data cut-off, and an encouraging OS hazard ratio of 0.51 (95% CI: 0.21–1.17; p=0.110) with median not reached at data cut-off.


CALYPSO Phase I/II study of savolitinib in combination with IMFINZI



®



PD-L1 inhibitor in RCC (


NCT02819596


)
– The CALYPSO study is an investigator initiated open-label Phase I/II study of savolitinib in combination with IMFINZI®, a PD-L1 antibody owned by AstraZeneca. The study is evaluating the safety and efficacy of the savolitinib /IMFINZI® combination in patients with papillary RCC and clear cell RCC. An analysis of 41 patients enrolled in the PRCC cohort of in this study was presented at the 2021 ASCO Annual Meeting18, showing a confirmed response rate in 8 out of 14 MET-driven patients, or 57%, with a median DoR of 9.4 months, median PFS of 10.5 months and median OS of 27.4 months. No new safety signals were seen.


SAMETA Phase III study in combination with IMFINZI



®



PD-L1 inhibitor in MET-driven, unresectable and locally advanced or metastatic PRCC (in planning)

Based on the encouraging results of the SAVOIR and CALYPSO studies, we are planning to initiate SAMETA, a global Phase III, open-label, randomized, controlled study of savolitinib plus IMFINZI® versus sunitinib monotherapy versus IMFINZI® monotherapy in patients with MET-driven, unresectable and locally advanced or metastatic PRCC.

Savolitinib development in gastric cancer


Phase II study of savolitinib



®



monotherapy in advanced or metastatic MET amplified gastric cancer (“GC”) or adenocarcinoma of the gastroesophageal junction (“GEJ”) (


NCT04923932


)
– This is an open-label, two-cohort, multi-center study to evaluate the efficacy, safety and pharmacokinetics (PK) of ORPATHYS® in locally advanced or metastatic GC or GEJ patients whose disease progressed after at least one line of standard therapy.

Savolitinib development in other cancer indications

Savolitinib opportunities are also continuing to be explored in multiple other MET-driven tumor settings via investigator-initiated studies including colorectal cancer.

About TAGRISSO

®

TAGRISSO® is a third-generation, irreversible EGFR TKI with clinical activity against central nervous system metastases. TAGRISSO® (40mg and 80mg once-daily oral tablets) has been used to treat more than 325,000 patients across indications worldwide and AstraZeneca continues to explore TAGRISSO® as a treatment for patients across multiple stages of EGFR-mutated NSCLC.

In Phase III trials, TAGRISSO® is being tested in the neoadjuvant resectable setting (NeoADAURA), in the Stage III locally advanced unresectable setting (LAURA) and, in combination with chemotherapy, in the Stage III locally advanced or Stage IV metastatic settings (FLAURA2). AstraZeneca is also researching ways to address tumor mechanisms of resistance through the SACHI and SANOVO Phase III trials, as well as the SAVANNAH and ORCHARD Phase II trials, which test TAGRISSO® given concomitantly with savolitinib, as well as other potential new medicines.

About HUTCHMED

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,400 personnel has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.


Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of ORPATHYS

®

for the treatment of patients with NSCLC, the further clinical development of ORPATHYS

®

in this and other indications, its expectations as to whether clinical studies of ORPATHYS

®

would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of its data to support New Drug Application approval of ORPATHYS

®

for the treatment of patients with NSCLC in China, its potential to gain expeditious approvals for ORPATHYS

®

in other jurisdictions such as the U.S., E.U. or Japan, the safety profile of ORPATHYS

®

, the potential for ORPATHYS

®

to become a new standard of care for NSCLC patients, its ability to implement and complete its further clinical development plans for ORPATHYS

®

, its potential commercial launch of ORPATHYS

®

in China and other jurisdictions, the timing of these events, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of TAGRISSO

®

and IMFINZI

®

as combination therapeutics with ORPATHYS

®

, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of TAGRISSO

®

and IMFINZI

®

. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and with The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

CONTACTS

Investor Enquiries  
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
   
Media Enquiries  
Americas – Brad Miles,
Solebury Trout
+1 (917) 570 7340 (Mobile)
[email protected]
Europe – Ben Atwell / Alex Shaw,
FTI Consulting
+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
[email protected]
Asia – Zhou Yi,
Brunswick
+852 9783 6894 (Mobile)
[email protected]
   
Nominated Advisor  
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited
+44 (20) 7886 2500

 

_________________________________________________________

1 World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed June 2021.
2 World Health Organization. International Agency for Research on Cancer. Globocan China Fact Sheet 2020. Available at http://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf. Accessed June 2021.
3 LUNGevity Foundation. Types of Lung Cancer. Available at https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer. Accessed June 2021.
4 Cagle P, et al. Lung Cancer Biomarkers: Present Status and Future Developments. Archives Pathology Lab Med. 2013;137:1191-1198.
5 Le Chevalier T, et al. Adjuvant Chemotherapy for Resectable Non-Small Cell Lung Cancer: Where is it Going? Ann Oncol. 2010;21:vii196-vii198.
6 Pignon J, et al. Lung Adjuvant Cisplatin Evaluation: A Pooled Analysis by the LACE Collaborative Group. J ClinOncol. 2008;26:3552-3559.
7 Zhang YL, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48):78985-78993. doi:10.18632/oncotarget.12587
8 Keedy V.L., et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J ClinOncol. 2011:29;2121-27.
9 Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol. 2013:66;79-89.
10 Cross DA, et al. AZD9291, an Irreversible EGFR TKI, Overcomes T790M-Mediated Resistance to EGFR Inhibitors in Lung Cancer. Cancer Discov. 2014;4(9):1046-1061.
11 Organ SL, et al. An overview of the c-MET signaling pathway. TherAdv Med Oncol 2011; 3(1Suppl): S7-S19.
12 Ramalingham SS, et al. Mechanisms of acquired resistance to first-line osimertinib: Preliminary data from the phase III FLAURA study. Ann Oncol. 2018; 29, SUPPLEMENT 8, VIII740. DOI:https://doi.org/10.1093/annonc/mdy424.063
13 Sterlacci W, et al. MET overexpression and gene amplification: prevalence, clinico-pathological characteristics and prognostic significance in a large cohort of patients with surgically resected NSCLC. Virchows Arch. 2017;471(1):49-55. doi:10.1007/s00428-017-2131-1
14 Lu S, et al. Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study. Lancet Respir Med. 2021 Jun 21:S2213-2600(21)00084-9. doi: 10.1016/S2213-2600(21)00084-9.
15 Sequist LV, et al. Osimertinib plus savolitinib in patients with EGFR mutation-positive, MET-amplified, non-small-cell lung cancer after progression on EGFR tyrosine kinase inhibitors: interim results from a multicentre, open-label, phase 1b study. Lancet Oncol. 2020;21(3):373-386. doi:10.1016/S1470-2045(19)30785-5.
16 Han J, et al. FP14.03 Osimertinib + Savolitinib in pts with EGFRm MET-Amplified/Overexpressed NSCLC: Phase Ib TATTON Parts B and D Final Analysis. J ThoracOncol. 2021;16(3S):S227-S228. doi: 10.1016/j.jtho.2021.01.146.
17 Choueiri TK, et al. Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Aug 1;6(8):1247-1255. doi: 10.1001/jamaoncol.2020.2218.
18 Suarez C, et al. Clinical activity of durvalumab and savolitinib in MET-driven, metastatic papillary renal cancer. JClinOncol 39, no. 15_suppl (May 20, 2021) 4511-4511. doi: 10.1200/JCO.2021.39.15_suppl.4511.

 



Beam Therapeutics to Participate in the 2021 Wells Fargo Virtual Healthcare Conference

CAMBRIDGE, Mass., Sept. 08, 2021 (GLOBE NEWSWIRE) — Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced that John Evans, chief executive officer, will participate in a fireside chat during the 2021 Wells Fargo Virtual Healthcare Conference on Friday, Sept. 10, 2021 at 9:20 a.m. ET.

The live webcast will be available in the investor section of the company’s website at www.beamtx.com. The webcast will be archived for 60 days following the presentation.

About Beam Therapeutics

Beam Therapeutics (Nasdaq: BEAM) is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that enables precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This enables a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Contacts:

Investors:
Chelcie Lister
THRUST Strategic Communications
[email protected]

Media:
Dan Budwick
1AB
[email protected]



Citizens Financial Group, Inc. to Acquire JMP Group LLC

Citizens Financial Group, Inc. to Acquire JMP Group LLC

Expands capital markets capabilities for commercial clients

Deepens expertise in healthcare, technology, financial services and real estate sectors

PROVIDENCE, R.I. & SAN FRANCISCO–(BUSINESS WIRE)–
Citizens Financial Group, Inc. (NYSE: CFG or “Citizens”) and JMP Group LLC (NYSE: JMP or “JMP”) announced today that they have entered into a definitive merger agreement under which Citizens will acquire JMP in an all-cash transaction.

JMP is a highly regarded capital markets firm that provides investment banking services, including strategic advisory, equity research and sales and trading focused primarily on the healthcare, technology, financial services and real estate sectors. Upon the closing of the transaction, JMP, which was founded in 1999 and is headquartered in San Francisco, will operate as a wholly-owned subsidiary of Citizens.

“The acquisition of JMP represents an attractive opportunity for us to continue to broaden both our capabilities and our customer base in our commercial banking segment,” said Bruce Van Saun, chairman and chief executive officer at Citizens. “The acquisition further strengthens Citizens’ growing corporate finance and strategic advisory capabilities, with a focus on high growth and compelling industry sectors.”

“We are adding a wealth of talented bankers as well as an institutional equities franchise that aligns well with our sector-focused corporate banking philosophy,” added Donald McCree, vice chairman and head of commercial banking at Citizens. “The transaction brings us a strong platform based in San Francisco and New York, expanding both our range of services and our national presence.”

“Citizens takes an approach to business and client service that mirrors our own,” said Joseph Jolson, founder and chairman of JMP. “We are energized by the opportunity to provide new strategic advisory and equities capabilities to Citizens’ corporate client base while simultaneously offering JMP Securities’ clients a highly complementary set of products and services as part of a leading U.S. depository institution.”

Under the terms of the merger agreement, JMP shareholders will receive $7.50 for each common share of JMP they own, or approximately $149 million in cash.

The merger agreement has been unanimously approved by the boards of directors of each company, and the transaction is targeted to close in the fourth quarter of 2021, subject to approval by the shareholders of JMP, receipt of required regulatory approvals, and satisfaction of other customary closing conditions. As of September 1, 2021, executive management and members of JMP’s board of directors owned approximately 60% of its outstanding common shares.

Sullivan & Cromwell, LLP served as legal advisor to Citizens in connection with the transaction. Keefe, Bruyette & Woods, A Stifel Company, and JMP Securities LLC served as financial advisors to JMP, and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. served as legal advisor.

Additional Information

A presentation providing additional information on the transaction is available at https://investor.citizensbank.com/about-us/investor-relations/events-and-presentations/2021.aspx.

Cautionary Statement About Forward-Looking Statements

This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the financial condition, results of operations, business plans and future performance of Citizens and JMP. Words such as “anticipates,” “believes,” “estimates,” “expects,” “forecasts,” “intends,” “plans,” “projects,” “targets,” “designed,” “could,” “may,” “should,” “will” or other similar words and expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Citizens’ and JMP current expectations and assumptions regarding Citizens’ and JMP businesses, the economy, and other future conditions.

Because forward-looking statements relate to future results and occurrences, they are subject to inherent risks, uncertainties, changes in circumstances and other factors that are difficult to predict. Many possible events or factors could affect Citizens’ and/or JMP’s future financial results and performance and could cause the actual results, performance or achievements of Citizens and/or JMP to differ materially from any anticipated results expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, (1) the risk that the cost savings, any revenue synergies and other anticipated benefits of the proposed transaction may not be realized or may take longer than anticipated to be realized, including as a result of the impact of, or problems arising from, the integration of the two companies or as a result of the condition of the economy and competitive factors in areas where Citizens and JMP do business, (2) disruption to the parties’ businesses as a result of the announcement and pendency of the proposed transaction and diversion of management’s attention from ongoing business operations and opportunities, (3) the occurrence of any event, change or other circumstances that could give rise to the right of one or both of the parties to terminate the definitive merger agreement between Citizens and JMP, (4) the risk that the integration of Citizens’ and JMP’s operations will be materially delayed or will be more costly or difficult than expected or that Citizens and JMP are otherwise unable to successfully integrate their businesses, (5) the failure to obtain the necessary approvals of the stockholders of JMP, (6) the outcome of any legal proceedings that may be instituted against Citizens and/or JMP, (7) the failure to obtain required governmental approvals or a delay in obtaining such approvals (and the risk that such approvals may result in the imposition of conditions that could adversely affect the combined company or the expected benefits of the proposed transaction), (8) reputational risk and potential adverse reactions of Citizens’ and/or JMP’s customers, suppliers, employees or other business partners, including those resulting from the announcement or completion of the proposed transaction, (9) the failure of any of the closing conditions in the definitive merger agreement to be satisfied on a timely basis or at all, (10) delays in closing the proposed merger, (11) the possibility that the proposed merger may be more expensive to complete than anticipated, including as a result of unexpected factors or events, (12) the applicability of the Bank Holding Company Act (including the Volcker Rule) to JMP, (13) general competitive, economic, political and market conditions, (14) other factors that may affect future results of JMP and/or Citizens including changes in asset quality and credit risk, the inability to sustain revenue and earnings growth, changes in interest rates and capital markets, inflation, customer borrowing, repayment, investment and securities, trading and deposit practices, the impact, extent and timing of technological changes, capital management activities, and other actions of the Federal Reserve Board, Securities and Exchange Commission (the “SEC”), Financial Industry Regulatory Authority and legislative and regulatory actions and reforms, and (15) the impact of the ongoing global COVID-19 pandemic on Citizens’ and/or JMP’s businesses, the ability to complete the proposed transaction and/or any of the other foregoing risks.

Except to the extent required by applicable law or regulation, each of Citizens and JMP disclaims any obligation to update such factors or to publicly announce the results of any revisions to any of the forward-looking statements included in this communication to reflect future events or developments. Further information regarding Citizens, JMP and factors which could affect the forward-looking statements contained herein can be found in Citizens’ Annual Report on Form 10-K for the fiscal year ended December 31, 2020, its subsequent Quarterly Reports on Form 10-Q, and its other filings with the SEC, and in JMP’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, its subsequent Quarterly Reports on Form 10-Q, and its other filings with the SEC.

Additional Information and Where to Find It

This communication may be deemed to be solicitation material in respect of the proposed acquisition of JMP by Citizens. In connection with the proposed transaction, JMP intends to file relevant materials with the SEC, including JMP’s proxy statement on Schedule 14A. JMP SHAREHOLDERS ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING JMP’S PROXY STATEMENT WHEN IT IS AVAILABLE, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE TRANSACTION. Investors and security holders will be able to obtain the documents free of charge on the SEC’s website at www.sec.gov, and JMP shareholders will receive information at an appropriate time on how to obtain documents free of charge from JMP that are not currently available.

Participants in Solicitation

JMP and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the holders of JMP common shares in respect of the proposed transaction. Citizens and its directors and officers are not a participant in such solicitation of proxies. Information about JMP’s directors and executive officers is set forth in the proxy statement for JMP’s 2021 Annual General Meeting of Shareholders, which was filed with the SEC on April 28, 2021. Other information regarding the participants in the solicitation of proxies in respect of the proposed transaction and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement to be filed by JMP and other relevant materials to be filed with the SEC. Free copies of these documents, when available, may be obtained as described in the preceding paragraph.

The information contained in this communication does not constitute an offer to sell or a solicitation of an offer to buy any securities or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

About Citizens Financial Group, Inc.

Citizens Financial Group, Inc. is one of the nation’s oldest and largest financial institutions, with $185.1 billion in assets as of June 30, 2021. Headquartered in Providence, Rhode Island, Citizens offers a broad range of retail and commercial banking products and services to individuals, small businesses, middle-market companies, large corporations and institutions. Citizens helps its customers reach their potential by listening to them and by understanding their needs in order to offer tailored advice, ideas and solutions. In Consumer Banking, Citizens provides an integrated experience that includes mobile and online banking, a 24/7 customer contact center and the convenience of approximately 3,000 ATMs and approximately 1,000 branches in 11 states in the New England, Mid-Atlantic and Midwest regions. Consumer Banking products and services include a full range of banking, lending, savings, wealth management and small business offerings. In Commercial Banking, Citizens offers a broad complement of financial products and solutions, including lending and leasing, deposit and treasury management services, foreign exchange, interest rate and commodity risk management solutions, as well as loan syndication, corporate finance, merger and acquisition, and debt and equity capital markets capabilities. More information is available at www.citizensbank.com or visit us on Twitter, LinkedIn or Facebook.

About JMP Group LLC

JMP Group LLC is a diversified capital markets firm that provides investment banking, equity research, and sales and trading services to corporate and institutional clients as well as alternative asset management products and services to institutional and high-net-worth investors. JMP conducts its investment banking and research, sales and trading activities through JMP Securities and its venture capital and private capital activities through Harvest Capital Strategies and JMP Asset Management. For more information, visit www.jmpg.com.

Media: Peter Lucht — 781.655.2289

Investors: Kristin Silberberg — 203.900.6854

KEYWORDS: United States North America California Rhode Island

INDUSTRY KEYWORDS: Other Professional Services Professional Services Finance

MEDIA:

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Design Therapeutics Announces Positive Preclinical Data Highlighting Disease-Modifying Potential of its Novel DM1 GeneTACs as a Treatment for Myotonic Dystrophy Type-1

Data to be Presented during the 2021 Virtual Myotonic Dystrophy Foundation Annual Conference

CARLSBAD, Calif., Sept. 08, 2021 (GLOBE NEWSWIRE) — Design Therapeutics, Inc. (Nasdaq: DSGN), a biotechnology company developing small molecule treatments for degenerative genetic disorders, today announced new preclinical data from its novel DM1 GeneTAC™ program, which demonstrated a near-complete resolution of disease-causing foci and correction of splicing defects in myotonic dystrophy type-1 (DM1) patient cells. These data will be presented in a poster titled “Small molecule GeneTACs reduce toxic nuclear foci and correct splicing defects in multiple DM1 cell types,” at the 2021 Virtual Myotonic Dystrophy Foundation Annual Conference, being held virtually from September 10-11, 2021.

“DM1 is a devastating multi-system genetic disorder caused by a nucleotide repeat expansion in the DMPK gene that leads to progressive muscle weakness, and also affects the heart, the gastrointestinal and endocrine systems, and ultimately impairs respiration. There are currently no approved treatment options,” said João Siffert, M.D., president and chief executive officer of Design Therapeutics. “Our DM1 GeneTACs are small molecules designed to address the underlying root causes of DM1 by specifically blocking transcription of the mutant DMPK gene.”

“New preclinical data demonstrated the ability of our DM1 GeneTACs to potently and selectively block expression of the mutant DMPK gene in DM1 patient cells. Reduction of nuclear foci was associated with clear correction of splicing defects that are involved in the multi-system pathophysiology of DM1,” added Abhi Bhat, Ph.D., head of R&D of Design Therapeutics. “We believe these data are highly meaningful both for the potential treatment of patients with DM1, as well as further validation of our GeneTAC approach to treating inherited degenerative diseases.”

Design is leveraging its proprietary GeneTAC (gene targeted chimera) platform to develop therapeutic candidates for inherited diseases driven by nucleotide repeat expansions, such as DM1. DM1 is caused by an increased number of CTG triplet repeats in the DMPK gene. Transcription of the mutant DMPK gene forms pre-mRNAs with large CUG hairpin loops that trap splicing proteins in the nucleus. Specifically, the mutant DMPK pre-mRNAs trap a critical CUG-binding protein called muscle blind-like protein 1 (MBNL1), which leads to the formation of toxic nuclear foci. These foci inhibit the ability of MBNL1 to process pre-mRNAs, which when mis-spliced disrupt muscle development and function that is characteristic of DM1.

Design’s DM1 GeneTAC program is designed to block transcription of the mutant DMPK gene and prevent the formation of the CUG hairpin structures that trap MBNL1, thereby addressing the underlying cause of the disease. New preclinical data being presented from studies of Design’s DM1 GeneTAC showed:

  • near-complete resolution of toxic nuclear foci of greater than 90% in DM1 patient fibroblasts and myoblasts, with dose-responsive resolution at concentrations less than 100 nM;
  • near-complete correction of splicing defects in the MBNL1 gene of greater than 90% in DM1 patient myoblasts, also at concentrations less than 100 nM;
  • highly selective knockdown of the mutant DMPK allele without affecting the normal, wild-type allele following a 72-hour treatment period in patient fibroblasts;
  • resolution of CUG foci at substantially greater levels than with antisense oligonucleotide controls in both primary myotubes and primary myoblast patient cells;
  • redistribution of MBNL1 from aggregates in DM1 patient-derived myotubes; and
  • biodistribution to key tissues implicated in DM1, skeletal muscle and heart, at concentrations above those needed to reverse splicing defects in vitro at doses that were well-tolerated in rodents.

These data, supplemented by a growing body of data from the company’s GeneTAC program for Friedrich ataxia, support the continued advancement of the DM1 program and rationale to evaluate the utility of the GeneTAC approach in multiple additional nucleotide repeat expansion diseases.


About Design Therapeutics


Design Therapeutics, Inc. (Nasdaq: DSGN) is a biotechnology company developing a new class of therapies based on a platform of gene targeted chimera (GeneTAC™) small molecules. The company’s GeneTAC molecules are designed to either turn on or turn off a specific disease-causing gene to address the underlying cause of disease. Design’s lead program is focused on the treatment of Friedreich ataxia, followed by a program in myotonic dystrophy type-1 and discovery efforts for multiple other serious degenerative disorders caused by nucleotide repeat expansions. For more information, please visit designtx.com.

Forward Looking Statements

Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to: preclinical data and the relevance of such data; Design’s DM1 GeneTAC program and its design and potential therapeutic benefits and advantages; and Design’s GeneTAC approach. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “designed to,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Design’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing therapies that are safe and effective for use as human therapeutics and operating as a development stage company; Design’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; the risk that promising early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials; changes in Design’s plans to develop and commercialize its product candidates; the risk that Design may not obtain approval to market its product candidates; uncertainties associated with performing clinical trials, regulatory filings and applications; risks associated with reliance on third parties to successfully conduct clinical trials and preclinical studies; changes in Design’s plans to develop and commercialize its product candidates; Design’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; Design’s reliance on key third parties, including contract manufacturers and contract research organizations; Design’s ability to obtain and maintain intellectual property protection for its product candidates; our ability to recruit and retain key scientific or management personnel; competition in the industry in which Design operates; and market conditions. For a more detailed discussion of these and other factors, please refer to Design’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of Design’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, as filed with the SEC on August 9, 2021. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Design undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

Contact:

Chelcie Lister
THRUST Strategic Communications
(910) 777-3049
[email protected]